Back to resultsThe SWOAR Trial Sparing of Swallowing and Aspiration Related Organs at Risk & Submandibular Gland With Intensity Modulated Radiotherapy Versus Standard IMRT in Head and Neck Squamous Cell Carcinomas (SWOAR)
Primary Purpose
Head and Neck Neoplasms, Swallowing Sparing IMRT
Status
Recruiting
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Swallowing and submandibular sparing IMRT
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Neoplasms focused on measuring IMRT, Dysphagia, Aspiration, Head and neck cancer, Radiation
Eligibility Criteria
Inclusion Criteria:
- Aged 18 or above and less than 70 years
- Patient undergoing radiotherapy for HNSCC of the Oropharynx or Larynx or Hypopharynx.
- Stage T1-4, N0-3, M0 disease with histologically confirmed squamous cell carcinoma requiring bilateral neck radiotherapy and where sparing of contra lateral or one submandibular gland is possible
- Radiotherapy with concomitant chemotherapy (unless contraindicated) is the planned treatment
- Karnofsky performance score greater or equal 70
- Available to attend long term follow- up;
- Ability to complete the MD Anderson Dysphagia Inventory (MDADI) and EORTC quality of life questionnaires English or Hindi Version.
- Willingness to undergo FEES.
- Written informed consent for treatment.
- Available to attend long term follow- up
Exclusion Criteria:
- Early Carcinoma Glottis (T1-T2, N0M0)
- Metastatic disease.
- Previous radiotherapy to the head and neck region
- Lateralised tumours, requiring unilateral irradiation
- Patients requiring radiation to both submandibular glands
- Evidence of pre-existing swallowing dysfunction (not related to HNC);
- Major head and neck surgery (excluding biopsies/tonsillectomy);
- Tracheostomy placement
- Previous or concurrent illness, which in the investigator's opinion would interfere with completion of therapy, trial assessments or follow-up
- Any invasive malignancy within previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ).
Sites / Locations
- Nci, AiimsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard IMRT
Swallowing Sparing IMRT
Arm Description
Standard IMRT with radical CRT/RT
Standard IMRT with radical CRT/RT with additional sparing of dysphagia-aspiration related structures & submandibular gland sparing by SWOAR-IMRT
Outcomes
Primary Outcome Measures
Change in swallowing function post radiotherapy
Primary objective of the SWOAR trial is to determine whether sparing the DARS by SWOAR IMRT, changes swallowing function compared to S- IMRT in advanced HNSCC. The impact of sparing the DARS with SWOAR-IMRT on late swallowing function will be evaluated the MDADI. Difference in the mean composite score of MDADI, a patient-reported outcome, at 6 months post radiotherapy is the primary outcome of the trial. MDADI score ranges from 0-100 where 0 is the worst and 100 is the best score for dysphagia assessment
Secondary Outcome Measures
Swallowing assessment
Swallowing will be assessed by using the MDADI at baseline, at completion of CRT/RT, 3, 6, 12, and 24 months.
Aspiration assessment
Longitudinal assessment of aspiration prevention as evaluated by FEES by the 8 point penetration-aspiration score. Patients will be subjected to 10 ml of liquid, semi solid and solid meal at baseline, at completion of CRT/RT, 3, 6, 12 and 24 months.6, 12, and 24 months.
Acute Toxicity
Assessment of acute weekly during radiotherapy as per RTOG
RTOG grading is from 0 to IV where 0 represents no findings and IV being the worst Findings
Late Toxicity assessment by RTOG
Assessment of late toxicity at 3, 6, 12, and 24 months post treatment as per RTOG score.
RTOG is from 0 to IV where 0 represents no findings and IV being the worst Findings
Late Toxicity assessment by LENT SOMA
Assessment of late toxicity at 3, 6, 12, and 24 months post treatment as LENT SOMA score.
LENT SOMA score is from 0 to IV where 0 represents no findings and IV being the worst Findings
Treatment outcome: Loco-regional tumor control
Loco-regional tumor control at 2 years At follow up of 3, 6, 12, and 24 months post treatment
Treatment outcome: Overall survival
Overall survival at 2 years At follow up of 3, 6, 12, and 24 months post treatment
Quality of life assessment: EORTC QLQ C-30
EORTC QLQ C-30 questionnaire At follow up of 3, 6, 12, and 24 months post treatment The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Quality of life assessment: EORTC QLQ HN35
As per the EORTC QLQ HN35 questionnaire At follow up of 3, 6, 12, and 24 months post treatment The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning). The scoring approach for the QLQ-H&N35 is identical in principle to that for the symptom scales / single items of the QLQ-C30.
Full Information
NCT ID
NCT05187091
First Posted
August 18, 2021
Last Updated
January 17, 2022
Sponsor
All India Institute of Medical Sciences, New Delhi
1. Study Identification
Unique Protocol Identification Number
NCT05187091
Brief Title
The SWOAR Trial Sparing of Swallowing and Aspiration Related Organs at Risk & Submandibular Gland With Intensity Modulated Radiotherapy Versus Standard IMRT in Head and Neck Squamous Cell Carcinomas
Acronym
SWOAR
Official Title
The SWOAR Trial: A Phase III Trial Evaluating Sparing of Swallowing and Aspiration Related Organs at Risk & Submandibular Gland With Intensity Modulated Radiotherapy Versus Standard IMRT in Head and Neck Squamous Cell Carcinomas
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, New Delhi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of SWOAR TRIAL is to test sparing of Dysphagia/ Aspiration risk structures (DARS) and contra lateral submandibular gland by IMRT. HNSCC of the oropharynx, larynx and the hypopharynx treated with radical concurrent chemoradiotherapy or radiotherapy will be included in the trial. Patients will be randomized to SWOAR IMRT or standard IMRT.
Swallowing function will be evaluated the MD Anderson Dysphagia Inventory (MDADI) scoring. Difference in the mean composite score of MDADI, a patient-reported outcome, at 6 months post radiotherapy is the primary outcome of the trial.
Secondary Objectives include longitudinal assessment of aspiration prevention as evaluated by FEES by the 8 point penetration-aspiration score. Swallowing function, will be assessed by using the MDADI at baseline, at completion of CRT/RT, 3, 6, 12, and 24 months.
Assessment of acute and late toxicity assessed at baseline, weekly during radiotherapy and then at 3, 6, 12, and 24 months post treatment as per RTOG and LENT SOMA score, respectively.
Treatment outcomes will be assessed in terms of loco-regional tumor recurrence and overall survival, assessed at follow-up visits 3, 6, 12, and 24 months post treatment and then annually until 5 years post treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Neoplasms, Swallowing Sparing IMRT
Keywords
IMRT, Dysphagia, Aspiration, Head and neck cancer, Radiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard IMRT
Arm Type
No Intervention
Arm Description
Standard IMRT with radical CRT/RT
Arm Title
Swallowing Sparing IMRT
Arm Type
Experimental
Arm Description
Standard IMRT with radical CRT/RT with additional sparing of dysphagia-aspiration related structures & submandibular gland sparing by SWOAR-IMRT
Intervention Type
Radiation
Intervention Name(s)
Swallowing and submandibular sparing IMRT
Intervention Description
Standard IMRT with radical CRT/RT with additional sparing of dysphagia-aspiration related structures & submandibular gland sparing by SWOAR-IMRT
Primary Outcome Measure Information:
Title
Change in swallowing function post radiotherapy
Description
Primary objective of the SWOAR trial is to determine whether sparing the DARS by SWOAR IMRT, changes swallowing function compared to S- IMRT in advanced HNSCC. The impact of sparing the DARS with SWOAR-IMRT on late swallowing function will be evaluated the MDADI. Difference in the mean composite score of MDADI, a patient-reported outcome, at 6 months post radiotherapy is the primary outcome of the trial. MDADI score ranges from 0-100 where 0 is the worst and 100 is the best score for dysphagia assessment
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Swallowing assessment
Description
Swallowing will be assessed by using the MDADI at baseline, at completion of CRT/RT, 3, 6, 12, and 24 months.
Time Frame
longitudinal assessment till 2 years
Title
Aspiration assessment
Description
Longitudinal assessment of aspiration prevention as evaluated by FEES by the 8 point penetration-aspiration score. Patients will be subjected to 10 ml of liquid, semi solid and solid meal at baseline, at completion of CRT/RT, 3, 6, 12 and 24 months.6, 12, and 24 months.
Time Frame
longitudinal assessment till 2 years
Title
Acute Toxicity
Description
Assessment of acute weekly during radiotherapy as per RTOG
RTOG grading is from 0 to IV where 0 represents no findings and IV being the worst Findings
Time Frame
longitudinal assessment till 2 years
Title
Late Toxicity assessment by RTOG
Description
Assessment of late toxicity at 3, 6, 12, and 24 months post treatment as per RTOG score.
RTOG is from 0 to IV where 0 represents no findings and IV being the worst Findings
Time Frame
longitudinal assessment till 2 years
Title
Late Toxicity assessment by LENT SOMA
Description
Assessment of late toxicity at 3, 6, 12, and 24 months post treatment as LENT SOMA score.
LENT SOMA score is from 0 to IV where 0 represents no findings and IV being the worst Findings
Time Frame
longitudinal assessment till 2 years
Title
Treatment outcome: Loco-regional tumor control
Description
Loco-regional tumor control at 2 years At follow up of 3, 6, 12, and 24 months post treatment
Time Frame
2 years
Title
Treatment outcome: Overall survival
Description
Overall survival at 2 years At follow up of 3, 6, 12, and 24 months post treatment
Time Frame
2 years
Title
Quality of life assessment: EORTC QLQ C-30
Description
EORTC QLQ C-30 questionnaire At follow up of 3, 6, 12, and 24 months post treatment The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. High score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.
Time Frame
longitudinal assessment till 2 years
Title
Quality of life assessment: EORTC QLQ HN35
Description
As per the EORTC QLQ HN35 questionnaire At follow up of 3, 6, 12, and 24 months post treatment The head & neck cancer module incorporates seven multi-item scales that assess pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexuality. There are also eleven single items. For all items and scales, high scores indicate more problems (i.e. there are no function scales in which high scores would mean better functioning). The scoring approach for the QLQ-H&N35 is identical in principle to that for the symptom scales / single items of the QLQ-C30.
Time Frame
longitudinal assessment till 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged 18 or above and less than 70 years
Patient undergoing radiotherapy for HNSCC of the Oropharynx or Larynx or Hypopharynx.
Stage T1-4, N0-3, M0 disease with histologically confirmed squamous cell carcinoma requiring bilateral neck radiotherapy and where sparing of contra lateral or one submandibular gland is possible
Radiotherapy with concomitant chemotherapy (unless contraindicated) is the planned treatment
Karnofsky performance score greater or equal 70
Available to attend long term follow- up;
Ability to complete the MD Anderson Dysphagia Inventory (MDADI) and EORTC quality of life questionnaires English or Hindi Version.
Willingness to undergo FEES.
Written informed consent for treatment.
Available to attend long term follow- up
Exclusion Criteria:
Early Carcinoma Glottis (T1-T2, N0M0)
Metastatic disease.
Previous radiotherapy to the head and neck region
Lateralised tumours, requiring unilateral irradiation
Patients requiring radiation to both submandibular glands
Evidence of pre-existing swallowing dysfunction (not related to HNC);
Major head and neck surgery (excluding biopsies/tonsillectomy);
Tracheostomy placement
Previous or concurrent illness, which in the investigator's opinion would interfere with completion of therapy, trial assessments or follow-up
Any invasive malignancy within previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aman Sharma, MD
Phone
+917018529339
Email
amans757@gmail.com
Facility Information:
Facility Name
Nci, Aiims
City
Jhajjar
State/Province
Haryana
ZIP/Postal Code
124105
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aman Sharma, MD
Phone
+917018529339
Email
amans757@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The SWOAR Trial Sparing of Swallowing and Aspiration Related Organs at Risk & Submandibular Gland With Intensity Modulated Radiotherapy Versus Standard IMRT in Head and Neck Squamous Cell Carcinomas
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